# K200623: OssGuide

- Pathway: 510(k) (Traditional)
- Applicant: Sk Bioland Co., Ltd.
- Decided: Oct 2, 2020 after 207 days
- Product code: NPL (Barrier, Animal Source, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924408 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2005) Summary page 4.

## Indications for use
OssGuide is recommended for: * Simultaneous use of GBR-membrane (OssGuide) and implants; » Augmentation around implants placed in immediate extraction sockets; » Augmentation around implants placed in delayed extraction sockets; * Localized ridge augmentation for later implantation; * Alveolar ridge reconstruction for prosthetic treatment; * Aid regeneration of bone defects after root resection, cystectomy, removal of retained teeth; * Guided bone regeneration in dehiscence defects

Source page: https://510kreport.com/device/K200623
Methodology: https://510kreport.com/methodology